Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer

Kocaeli University

Status: Completed

Conditions: Endometrial Cancer; Sentinel Lymph Node

Treatments: Procedure: Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles; Procedure: Cervical injection of technetium 99 m-labeled human albumin colloid particles

Study type: Interventional

Funder types: Other

Identifiers

NCT03900104

CEIN

Details and patient eligibility

About

The investigators think that trans-cervical endometrial tracer injection will cause more paraaortic sentinel lymph node detection. Also, this application is easy, cost-effective and safer than hysteroscopic method. Transtubal tumor spearing will not occur with this method.

Full description

Endometrial tracer injection will be performed by cervical or transcervical endometrial methods. Pelvic and para-aortic sentinel lymph node detection capacity will be assessed in this study.

Enrollment: 81 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Endometrial Cancer Patients
• Suitable patients for surgical staging

Exclusion criteria

• Patients who cannot undergo cervical or transcervical endometrial injection
• Pathology did not confirm endometrial cancer
• Sarcoma of the uterine corpus
• If a 90-day follow-up was not feasible

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 2 patient groups

Transcervical endometrial injection arm

Experimental group

Description:

Tracer injection performed by a transcervical catheter in endometrial cancer patients.

Treatment:

Procedure: Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles

Cervical injection arm

Active Comparator group

Description:

Tracer injection was administered via the cervical route in endometrial cancer patients.

Treatment:

Procedure: Cervical injection of technetium 99 m-labeled human albumin colloid particles